A pre-marketing ALT signal predicts post-marketing liver safety

Article ID	Journal	Published Year	Pages	File Type
5857291	Regulatory Toxicology and Pharmacology	2012	7 Pages	PDF

Abstract

âº Prediction of hepatotoxic drugs pre-marketing is important for patient safety. âº We examined whether a pre-marketing “ALT signal” predicted post-marketing safety. âº Our ALT signal had a 71% positive predictive value for post-marketing liver safety. âº Ninety percent of studied drugs were safe post-marketing if they lacked an ALT signal.

Keywords

ULN EBGM FDA Disproportionality analysis AERS PDR mGPS DPA MedDRA IQR ALT NDA EMA Alanine aminotransferase European Medicines agency New drug application Upper limit of normal DILI Medical Dictionary for Regulatory Activities Food and Drug Administration Hepatotoxicity Adverse Event Reporting System interquartile range Drug induced liver injury